NCT05887674 Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
| NCT ID | NCT05887674 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-05-11 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2023-05-11 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria: 1. Aged 60-90 years 2. In accordance with the diagnostic criteria for "mild cognitive impairment due to Alzheimer's disease" or "mild Alzheimer's disease" from the National Institutes of Health National Institute on Aging-Alzheimer's Association (NIA-AA) (2011) 3. The Hamilton depression rating scale/17 edition (HAMD) total score≤10 4. Neurological examination: no obvious signs 5. Education: primary school (grade 6) or above and capacity to complete tests for cognitive ability 6. Capacity to give consent Exclusion Criteria: 1. Other causes of cognitive decline: cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's and Parkinson's disease, Creutzfeldt-Jakob disease, traumatic brain dementia, other physical and chemical factors (such as drugs, alcohol, CO), systemic disease (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupation (a subdural hematoma, brain tumor), the endocrine system disease (thyroid disease, parathyroid disease), and vitamins deficiency or any other causes of dementia 2. The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc 3. Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium 4. There are unstable or serious heart, lung, liver, kidney, endocrine, and hematopoietic system diseases, or Poor prognosis because of malignant diseases such as tumors. 5. Vision or hearing problems that lead to poor performance on cognitive tests 6. Two years history of severe alcoholism, and drug abuse 7. Participants who participated in any other trial 30 days prior to their screening visit 8. Contraindication of MRI scanning 9. Special requirements for diet, e.g., allergy to common food or on a special diet due to medical needs 10. Participants who cannot be followed for at least 6 months (due to a health situation or migration)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05887674 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 90 Years, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05887674 currently recruiting?
Yes, NCT05887674 is actively recruiting participants. Contact the research team at lby11917@rjh.com.cn for enrollment information.
Where is the NCT05887674 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05887674 clinical trial?
NCT05887674 is sponsored by Ruijin Hospital. The trial plans to enroll 180 participants.